Sotax takes over software specialist secom gmbh express. Winsotax advanced dissolution software is a 21 cfr part 11 compliant, validated on windows xp2000 software package that controls each of our automated dissolution systems as well as our spectrophotometers. Whether used standalone or in a networked environment, the modern clientserver architecture can be flexibly implemented for different needs. March 2014the sotax group, a global leader in the development and manufacturing of dissolution testing, automated sample preparation, and physical testing equipment for the pharmaceutical industry, launches the 4th generation sotax at md fully automated dissolution system. With hundreds of systems in operation, the at 70smart is helping pharmaceutical companies worldwide to remain competitive. Feasibility study secure your instrument investment with data confirmation of fit for purpose method capability on your products method development save time and resources by allowing sotax application scientists to. Sotaxs mission is to provide high quality and efficient equipment that yields accurate results.
Finding the best solution for your needs starts with one simple question. The at md is driven by the 21 cfr part 11 compliant md software. Discovering the best methods gets you the best results. Uplc can provide the versatility to discover the best set of chromatographic conditions for your sample, providing a more robust method. Equipnet is constantly receiving used sotax equipment through our exclusive contracts with our clients. Sotax also offers sps pharma services cro, contract research lab dedicated to dissolution testing research, method development and advanced training. Total revision august 2015 usp 1094 capsulesdissolution testing and related quality attributes usp 2040 disintegration and dissolution of dietary supplements ep 2. Sotax instruments meet all usp, ep, fda, fip guidelines and most sotax products are in compliance with 21 cfr. Dissolution testing of drug formulations was introduced in the 1960s and accepted by health regulatory authorities in the 1970s. Sotax helps pharmaceutical companies worldwide in overcoming the various challenges associated with feasibility studies, method development, method automation, method validation, and method transfer. On top of that it also features easy setup and method programming for manual or semiautomated test runs. Winsotax advanced dissolution software controls all sotax dissolution testing systems, as well as, our spectrophotometers.
Sotax is a leader in the development and manufacturing of test instruments and software for tablet testing and is a leading solution provider for the pharmaceutical industry. The at 70smart is driven by the 21 cfr part 11 compliant winsotaxplus advanced dissolution software. The sotax group, the global leader in the development and the manufacture of dissolution testing systems, automated sample preparation platforms and physical testing equipment for the pharmaceutical industry, has been working hand in hand with secom for over 20 years. The sotax at 7smart dissolution system is designed to determine the invitro drug release from common pharmaceutical dosage forms according to pharmacopoeia requirements. Sotax dissolution system the at md is a fully automated benchtop dissolution system and can handle basket and paddle methods as well as sinkers including japanese sinkers. The at md is a fully automated dissolution system that fits on your standard laboratory bench. Sotax dissolution system, model ch4123, sn 011028 va. Sotax instruments meet all cp, ep, jp, usp and fda guidelines and sotax.
Sotax is the global leader in providing highquality dissolution testing systems, composite assay and content uniformity workstations and physical tablet testing instruments for the pharmaceutical, dietary supplement, medical device and biopharmaceutical industries. The 21 cfr, part 11 compliant qdoc dissolution software from sotax fully integrates the uv7 spectrophotometer. Assets are intended to be sold without software, if any is applicable. Sotax flyer at7smart automation system 2006 euro teknokroma. At7 smart dissolution testing for usp apparatus 1, 2, 5 and 6. The sotax at 7smart dissolution tester is the ideal system for automated dissolution. Shapes and supports sotax as a member of the sotax usa board conceptualizing and authoring shortlong term strategic plans which prioritize developmental, production, and quality to deliver low. Sotax at7 smart semiautomated dissolution tester for. Sotax dissolution testing fully automated dissolution at 70smart.
Our equipment is used worldwide in the development and production processes of our customers and the pharmaceutical and science industries. Sotax corporation westborough, ma business information. Today sotax is a leader in the development and manufacturing of test instruments and software for tablet testing and is a leading solution provider for the. Usp 1092 the dissolution procedure development and validation. Method development and validation of dissolution testing. Sotax dissolution testing smart 10 winsotaxplus dissolution software winsotaxplus has been developed under the latest regulations including gamp, galp, iso 9001 software standards and completely complies with the rules and regulations of 21 cfr part 11 and data integrity set out by the fda. Since then, the importance of dissolution has grown rapidly as have. The photometers are completely integrated into the system software.
For sotax ag, the partnership with the jenabased high tech company is an opportunity to strengthen its position as a leading dissolution systems provider. Today sotax is a leader in the development and manufacturing of test instruments and software for tablet testing and is a leading solution provider for the pharmaceutical industry. This automated tablet dissolution analytical system provides unprecedented performance over and above that of any other hplc or uv dissolution system. Dissolution is the process of dissolving the drug substance from the solid state. The dissolution profile is used to demonstrate reliability and batchtobatch uniformity of the active ingredient.
Operated by 21 cfr part 11 compliant winsotax dissolution software alreadyknown and val. The sotax group is a leader in providing automated dissolution testing systems, sample prep workstations for content uniformity and assay testing, and tablet testing instruments for the. Sotax partners with thermo electron to sell and support the evolution 300 spectrophotometer. Certification, extended in 1999 to the tickit quality system for software development, thereby becoming the worlds first supplier of dissolution testing systems to receive this seal of quality. Winsotax advanced dissolution software pharmaceutical online. Automated dissolution improves the productivity of a lab creating walkawaytime for operators allowing more time for missioncritical activties such as method development, process validation, data checking, and verification. Since it takes up a minimum amount of space, it fits into any standard test laboratory. Dissolution testing is essential in the formulation, development, and production process for quality control and release in drug manufacturing. Builtin firmware for method programming and reporting. Allschwil, switzerland and horsham, pa, usa, january 2009. Sotax dissolution system 80002 9150 w cp7 pumpspecifications.
The sotax at 7smart dissolution tester is the ideal system for automated dissolution tests based on the stirrer methods. At7 smart dissolution testing for usp apparatus 1, 2, 5 and 6, at7 smart dissolution testing for usp apparatus 1, 2, 5 and 6the smarter choice for dissolution testing. Sotax, founded in 1973, began as an engineering company to service the pharmaceutical and other industries. Certification, extended in 1999 to the tickit quality system for software development, thereby becoming the worlds first supplier of dissolution testing systems to.
At sotax, we engineer solutions for development and quality control. Sotax dissolution system, model ch4123, sn 011028 va 25, 3 component type. It easily handles basket and paddle methods as well as sinkers including large japanese sinkers. Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution of the drug under physiological conditions, and the absorption across the gastrointestinal tract. Fully automated dissolution testing is defined as several unattended lots run in succession with media preparation.
Sotax at 7smart dissolution system with cp 735 piston. Fully automated dissolution testing system sotax india. Whether you perform dissolution tests occasionally or several times each day argusdissolution will make you more productive in running tests and analy. With hundreds of systems in operation worldwide, sotax. Customdesigned offline automation system with sample collection, solvent addi. Sotax leads the way in the development and manufacture of highquality pharmaceutical testing equipment and associated services. Sotax is well known for their advanced expertise and skills in their field, ensuring consumers are receiving the ideal equipment they need. Winsotax software is a 21 cfr part 11 compliant and validated on windows xp2000 software with a high level of data security. Sotax laboratory automation world pharmaceutical frontiers.
From setup fixed position vessels and autocentering through the complete dissolution test to. It runs up to 8 unattended batches from media preparation to data reporting. Sotax has a wide variety of manual and automatic dissolution. The next generation of dissolution software, winsotax plus, is a now a client. Atmd fully automated dissolution testing system youtube. Sotax dissolution testing fully automated dissolution at 70smart 7 the at 70smart fully automated dissolution system from prerun to postrun system cleaning, sotax streamlines your workflow through the design of features that guide method development and simplify routine operation. Sotax group takes over software specialist secom gmbh. The at md is a fully automated benchtop dissolution system and can handle. Our experts then assist in finding the most suitable system configuration, help with method development or method transfer if needed and support your team throughout the entire lifecycle of your xtend dissolution system. Read article with this acquisition, sotax group strengthens its portfolio in the data integritydriven field of data management solutions for analytical development laboratories, quality control departments and production sites in the pharmaceutical industry the sotax group has taken over the software specialist secom gmbh to further expand its position as the worlds leading solution.
Ajay pydah director device development and production. Sotax corporation winsotax advanced dissolution software is a 21 cfr part 11 compliant, validated on windows xp2000 software package that controls each of our automated dissolution systems as well as our spectrophotometers. Sotax dissolution testing fully automated dissolution at md. In 1996 sotax received the iso 9001 certification, extended in 1999 to the tickit quality system for software development, thereby becoming the worlds first supplier of dissolution testing systems to receive this seal of quality. The at 7smart is the result of 35 years of development, manufacturing and experience from our customers. From prerun to postrun system cleaning, sotax streamlines your workflow through the design of features that guide method development and simplify routine operation. In the event that software is included in an asset sale, notwithstanding the disclaimers set forth above, keith machinery makes no. Dissolution is defined as the process by which a solid substance enters in solvent to yield a solution. Sotax group, worldwide market leader in automated dissolution innovation, launches the new winsotax plus advanced dissolution software. Automated dissolution testing system sotax india pvt.
The new at md fully automated dissolution system from prerun to runtime to postrun system cleaning, sotax streamlines your workflow through the design of features that guide method development and simplify routine operation. The flexibility of modern uplc systems allows you to automatically screen key method parameters and help to automate your method development experiment. Systems can be configured using baths from pharma test, vankel, erweka, distek, electrolab, hanson, sotax and varian. Semi automated dissolution testing system sotax india pvt. Reducing cycle times and completing more work with existing resources. Once a sequence is started, the at md runs up to 8 unattended batches from media preparation to selfcleaning of the system. New sotax at7 smart semiautomated dissolution tester offline automation. Sotax introduces winsotax plus a client server dissolution software with improved features.
The design of sotax dissolution systems is compliant with all harmonized pharmacopeia requirements for paddle and basket methods. Sotax instruments meet all usp, ep, fda, fip guidelines and most sotax products are in compliance with 21 cfr part 11. Using the standard rs232 interface, test temperature, stirrer speed, automated tablet drop and start stop functions can be triggered and monitored from a pc through winsotax advanced dissolution software. Argusdissolution is a scientific dissolution data management software for instrument controle, data acquisition, data management, processing and reporting designed by users for users. We support you with expertise at each step of your process. Pharmaceutical testing services provider sotax explores examples of and considerations for automated method development. Automation of dissolution tests rolf rolli sotax ag basel, binningerstrasse 106, ch4123 allschwil, switzerland.
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